Not currently registered with FDA under this name

Champions Implants GmbH

Tuningen, Baden-Wuerttemberg, Germany. Named as applicant on 1 dental 510(k) clearance between 2010 and 2010. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12010–2010
Markets registered in: 432 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 4 markets

Where regulators' registries name Champions Implants GmbH as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: GermanyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Champions Implants GmbH	1 clearances	2010–2010	Below
European Union	EUDAMED	Manufacturer	Champions-Implants GmbH	26	—	Pure Global AI
Colombia	INVIMA	Registration holder	CHAMPIONS-IMPLANTS GMBH	4	—	Pure Global AI
Taiwan	TFDA	Manufacturer	CHAMPIONS-IMPLANTS GMBH	2	2013–2020	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Champions Implants GmbH as the applicant.

Decided	510(k)	Device	Device type
7 Jan 2010	K091182	CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000	DZE Root-Form Endosseous Implant

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.